NCT04824872

Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects

Conditions

• Hypoglycemia
• Glucose Metabolism Disorders

Interventions

Type	Name	Description
DRUG	Dasiglucagon	dasiglucagon SC, low dose
DRUG	Dasiglucagon	dasiglucagon SC, high dose
DRUG	Placebo	placebo for dasiglucagon

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2021-04-01
• Last updated: 2023-02-21

Regulatory

• FDA-regulated drug study